BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER, INC.

    MDR report key: 99571 · Received June 19, 1997

    Report

    Report Number
    58169-1997-00002
    Event Type
    Injury
    Date Received
    June 19, 1997
    Date of Event
    June 18, 1997
    Report Date
    June 19, 1997
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT TISSUE WAS COLORED BLACK AROUND THE PATELLA DOME. ALSO THE POLY WAS DISASSOCIATED FROM THE METAL BACKING. IT WAS CLEARLY SEEN THAT THE PATELLA'S METAL WAS TRACKING ON THE FEMORAL COMPONENT. COMPONENT IS IN THE POSSESSION OF THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER, INC. Implant 8504-852-32 PATELLA BUTTON HTG ZIMMER, INC. NA 57868000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention